Clinical Trial: Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants

Brief Summary: The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.

Detailed Summary:

Mechanical ventilation interferes with cerebral perfusion via the changes in intrathoracic pressure and/or as a consequence of hypocapnia. This latter occurs frequently following traditional ventilation strategies with relatively high tidal volume and respiratory rate. New trends in anesthesia intend to promote protective lung ventilation by keeping a normocapnic or even mildly hypercapnic state. However, cerebral vascular vasotonicity is carbon dioxide (CO2)-dependent with hypocapnia potentially leading to vasoconstriction and subsequent decrease in cerebral blood flow. Changes in cerebral vasoreactivity can be assessed by the near infrared spectroscopy (NIRS) device. This monitoring evaluates the changes in various parameters (deoxygenated hemoglobin, oxygenated hemoglobin, the tissue oxygenation index (TOI) and the tissue hemoglobin index (THI)) that act as surrogate for cerebral vasoconstriction.

We, therefore designed this prospective observational comparative effectiveness study in order to characterize the potential beneficial effect of permissive hypercapnia on cerebral perfusion in infants.


Sponsor: Walid HABRE

Current Primary Outcome: Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia [ Time Frame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood gas analysis [ Time Frame: 5 or 20 minutes after reaching the steady state with ETCO2 ]
    Assessment changes in oxygen partial pressure (PaO2), carbon dioxide partial pressure (PaCO2) and potential of hydrogen (pH) under one level of ETCO2
  • Blood Pressure [ Time Frame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level ]
    Non invasive monitoring of blood pressure
  • Heart rate [ Time Frame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level ]
    Non invasive recording of heart rate
  • Body temperature [ Time Frame: At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level ]
    Naso-pharyngeal temperature probe


Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: March 11, 2015
Date Started: September 2015
Date Completion: May 2017
Last Updated: October 30, 2016
Last Verified: October 2016